StrokeHOPESNCT02582502
Hyperbaric Oxygen Post Established Stroke
A study testing Hyperbaric Oxygen in people with Stroke and Ischemic Stroke, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Stroke, Ischemic Stroke, Established Stroke
- What is being tested?
- Hyperbaric Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 19 and 85.
- Able to speak English and give informed consent or have a substitute decision maker and able to assent.
- One or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months
- Able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes.
Who cannot join
- Contraindication to HBOT (Appendix C) including:
- Untreated collapsed lung (pneumothorax)
- Have taken the chemotherapy drug Doxorubicin within 72 hours
- Have taken the chemotherapy drug Bleomycin within 4 months
- Bowel obstruction
- Heart pacemaker of unknown make and model
Show all 11Show fewer
- Pregnancy
- Cigarette Smoking
- Chronic Obstructive Pulmonary Disease (COPD)
- Participation in other stroke related studies.
- Previous history stroke > 36 months prior to study baseline
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital - Hyperbaric Unit
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Hyperbaric Oxygen Post Established Stroke - HOPES - Study
The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.
Read the detailed description
The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.
Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. Some of these effects have been postulated to be beneficial in the context of ischemic stroke.
Most of the recovery after stroke occurs in the first 30 to 90 days after the acute event. Recovery is largely based on recovery of brain that is injured, but viable. Physiological imaging studies (PET, EEG) have demonstrated that brain tissue may remain alive but not functional for months or years after ischemic insult.
Subjects will be selected from the stroke population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will have suffered an ischemic stroke involving the cerebral cortex within the last 6 to 36 months. The study will be enrolling 140 subjects and will be randomized to two different treatment arms: experimental group and a waitlist group.
Each subject will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, 3 weeks and 6 weeks into treatment and then again at the end of treatment. After treatment ends, the investigators will conduct these assessments again at 3 months, 6 months, 9 months and 1 year from the date of the participants last treatment.
- Conditions
- Stroke, Ischemic Stroke, Established Stroke
- Being tested
- Hyperbaric Oxygen
- Keywords
- Hyperbaric Oxygen, HBOT, Hyperbaric Chamber, Pressurized Oxygen
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenOther
The only intervention given will be 100% oxygen under hyperbaric pressure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This arm will receive Hyperbaric Oxygen Therapy immediately after consent into study. Receives: Other: Hyperbaric Oxygen |
| Wait list Treatment | Other | This arm will receive Hyperbaric Oxygen Therapy two months after consenting into study. Receives: Other: Hyperbaric Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study
Measured: Pre treatment (Baseline and after waiting period is completed), During Treatment (3 weeks, 6 weeks) and Post Treatment (9 weeks post baseline, 8 months post and 14 months)
Secondary outcomes (12)
National Institute of Health Stroke Scale (NIHSS)
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Nine hole peg board
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Grip Strength
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Berg Balance Test
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
6 metre walk test
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
6 minutes walk test
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Trail Making Test
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Digital Symbol Substitution Test
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Centre for Epidemiologic Studies Depression Scale (CESD)
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Medical Outcomes Study Short Form (SF-36)
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Montreal Cognitive Assessment (MoCA)
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Health Economics Questionnaire
Measured: Pre treatment (Baseline and after waiting period) and Post Treatment (5 months, 8 months, 11 months and 14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2020
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Harrison, University of British Columbia
- Investigators
- David W Harrison, MD,CCFP(EM),FRCPC, Principal investigator, Vancouver General Hospital and University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582502
- Sponsor's protocol ID
- H15-00766
- Acronym
- HOPES
- Status last verified
- Mar 2020
- First submitted
- 29 Sep 2015
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Post Established Stroke - HOPES - Study
- ClinicalTrials.gov ID
- NCT02582502
- Acronym / sponsor ID
- HOPES / H15-00766
- Conditions
- Stroke, Ischemic Stroke, Established Stroke
- Keywords
- Hyperbaric Oxygen, HBOT, Hyperbaric Chamber, Pressurized Oxygen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.
Detailed description
The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.
Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. Some of these effects have been postulated to be beneficial in the context of ischemic stroke.
Most of the recovery after stroke occurs in the first 30 to 90 days after the acute event. Recovery is largely based on recovery of brain that is injured, but viable. Physiological imaging studies (PET, EEG) have demonstrated that brain tissue may remain alive but not functional for months or years after ischemic insult.
Subjects will be selected from the stroke population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will have suffered an ischemic stroke involving the cerebral cortex within the last 6 to 36 months. The study will be enrolling 140 subjects and will be randomized to two different treatment arms: experimental group and a waitlist group.
Each subject will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, 3 weeks and 6 weeks into treatment and then again at the end of treatment. After treatment ends, the investigators will conduct these assessments again at 3 months, 6 months, 9 months and 1 year from the date of the participants last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Hyperbaric OxygenThis arm will receive Hyperbaric Oxygen Therapy immediately after consent into study. |
| Wait list Treatment | Other | Other: Hyperbaric OxygenThis arm will receive Hyperbaric Oxygen Therapy two months after consenting into study. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 19 and 85.
- Able to speak English and give informed consent or have a substitute decision maker and able to assent.
- One or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months
- Able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes.
Key exclusion criteria (11 listed)
- Contraindication to HBOT (Appendix C) including:
- Participation in other stroke related studies.
- Previous history stroke > 36 months prior to study baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric OxygenThe only intervention given will be 100% oxygen under hyperbaric pressure. | Other | Treatment, Wait list Treatment |
Primary outcome
Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study
Time frame: Pre treatment (Baseline and after waiting period is completed), During Treatment (3 weeks, 6 weeks) and Post Treatment (9 weeks post baseline, 8 months post and 14 months)
12 secondary outcomes
National Institute of Health Stroke Scale (NIHSS)
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Nine hole peg board
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Grip Strength
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Berg Balance Test
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
6 metre walk test
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
6 minutes walk test
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Trail Making Test
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Digital Symbol Substitution Test
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Centre for Epidemiologic Studies Depression Scale (CESD)
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Medical Outcomes Study Short Form (SF-36)
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Montreal Cognitive Assessment (MoCA)
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Health Economics Questionnaire
Time frame: Pre treatment (Baseline and after waiting period) and Post Treatment (5 months, 8 months, 11 months and 14 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
RecruitingPhase 3
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
Acute Ischemic Stroke
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Harrison, MD,CCFP(EM),FRCPC principal investigator
Vancouver General Hospital and University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen in people with Stroke and Ischemic Stroke, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study (time frame: Pre treatment (Baseline and after waiting period is completed), During Treatment (3 weeks, 6 weeks) and Post Treatment (9 weeks post baseline, 8 months post and 14 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.